FDA 510(k)

IVYLASER ハンドホルダー式毛脱毛機

K番号: K230025 · 2023-07-03

申請者Ivylaser (Beijing) Technology Co.,Ltd

決定日2023-07-03

製品コードOHT

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

IVYLASER Handhold Hair Removal Machine is the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K230025. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the IVYLASER Handhold Hair Removal Machine?

IVYLASER Handhold Hair Removal Machine is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K230025.

When did IVYLASER Handhold Hair Removal Machine receive FDA 510(k) clearance?

IVYLASER Handhold Hair Removal Machine received FDA 510(k) clearance on 2023-07-03, under 510(k) number K230025.

Who is the listed applicant for IVYLASER Handhold Hair Removal Machine?

The FDA 510(k) record lists Ivylaser (Beijing) Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVYLASER Handhold Hair Removal Machine?

The FDA product code for IVYLASER Handhold Hair Removal Machine is OHT.

申請者としてIvylaser (Beijing) Technology Co.,Ltdを記載するその他の記録

K250206レーザーダイオードシステム（ナイトユニバース；プレデター）K240611IVYLASER ディオードレーザー毛脱毛システム（IVY-HR-Alloy）

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